Implementing Responsible Clinical Trial Data Sharing

Earlier this year, PhRMA member companies, along with member companies of the European Federation of Pharmaceutical Industries and Associations (EFPIA), announced new commitments to enhance responsible sharing of clinical trial data. The Principles for Responsible Clinical Trial Data Sharing: Our Commitment to Patients and Researchers reflect the biopharmaceutical sector’s strong support for appropriate data sharing that recognizes the importance of protecting patient privacy, respects the integrity of national regulatory systems, and maintains the incentives for continued investment in biopharmaceutical research necessary to provide patients with new treatment options. We firmly believe that continuing to augment the amount of information that is shared responsibly will expand research and scientific knowledge, foster a collaborative scientific discovery process, and support patient care – all with the ultimate goal of improving public health.

As we near the January 1, 2014 implementation date, biopharmaceutical companies are finalizing their processes for reviewing requests for data and engaging with qualified researchers. Today, Pfizer announced its updated policy and procedures on Pfizer.com and expanded its investigator-initiated research portal, INSPIIRE, to include a data request form for researchers. Pfizer’s President of Worldwide Research & Development, Dr. Mikael Dolsten, announced the updates at the company’s R&D Day in New York, which included:

A new system for reviewing data requests, including an outside Independent Review Panel

Publication of synopses of clinical study reports (CSRs) filed with regulatory agencies on Pfizer.com. About 200 CSRs are on the website today and more will be added over the course of 2014.

Lay-language summaries of clinical trial findings to be made available to trial participants for trials starting in 2014.

Piloting “Blue Button” technology to enable Pfizer trial participants to download their own medical data collected in the trial.

Biopharmaceutical companies already routinely collaborate with academic researchers, publish clinical research, and share clinical trial information on public websites such as ClinicalTrials.gov. The Principles will enhance those efforts by making additional information available to the public, the patients who volunteer to participate in clinical trials, and qualified researchers. Other PhRMA member companies, such as GSK, have also published their procedures for sharing data.

The PhRMA/EFPIA Principles, and the implementation efforts by companies like Pfizer, offer a responsible alternative to proposed policies by the European Medicines Agency (EMA) and demonstrate the industry’s commitment to sharing data responsibly as part of a larger and evolving effort by all who create and use clinical data to arrive at a transparent, harmonized process for researchers to access patient-level data for clinical trials.

More importantly, the Principles advance science and help bring needed treatments one step closer to reality. This is what matters to patients and that is our primary focus and responsibility.

We will continue to provide updates on the implementation of the Principles, so watch this space for further news.